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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).
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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.
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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.
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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.
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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.
Time: 12-1 pm
To Sign-up: Link to ACRP eConsent Webinar
Registration Deadline: February 27, 2017
Description:
In this webinar Sandra “SAM” Sather, VP, Clinical Pathways, Regulatory & Quality lead for eConsent, CRF Health Trial Consent and Michael Conde, is the Senior Director of Technical Solutions at CRF Health discuss how eConsent (eIC) improves investigator, sponsor and IRB oversight for informed consent and decreases risks.
Part 2 of this series summarized the background and need for the upcoming updates to ICH E6 and ICH E8 per the ICH’s reflection paper that is currently available here and is open to stakeholder comment until March 27th. Section 2 of the reflection paper “Proposed Structure for a Modernized ICH E8 Guideline and a Future Renovated ICH E6 Guideline” focuses on ICH E8 explaining the need for modernization.
Part 1 of this series summarized the purpose and intention for the upcoming updates to ICH E6 and ICH E8 per the ICH’s reflection paper that is currently available here and is open to stakeholder comment until March 11th. The background section first evaluates the current state of ICH E6 and explains the need for renovation.
Date: February 23, 2017
Live Webinar Time: 3 pm London / 10 am New YorkDuration: 60 Minutes - Online
Description:
The new reality of our industry reveals the need for implementing further initiatives to improve trial oversight and enable a better experience for all stakeholders.
The research landscape has changed over the course of the last several decades to accommodate increased complexity along with broader population samples for the assessment of new therapeutic interventions causing a new set of human subject protection challenges. Time and cost of clinical trials are always a pain point in the industry and many initiatives have been launched to address it. Here in the US research funding plays a major role in IRB selection since most institutions insist on using a local IRB for non-industry-sponsored research even as the FDA and OHRP have encouraged the use of central IRBs.
